• Site Investigator Embraces "Whole-Body" Approach to HIV Treatment and Clinical Trial Design

    March 30, 2016 pendari Sites

    Meet Dr. Grace McComsey

    Grace McComsey, MD, is an Investigator and Professor of Pediatrics and Medicine and Chief, Pediatric Infectious Diseases and Rheumatology at our Case Western Reserve University Clinical Research Site in Cleveland, OH. She has worked with both children and adults living with HIV for over 15 years and during that time she has seen HIV treatment shift from being solely based on viral loads and CD4 counts to a more comprehensive and holistic approach. Dr. McComsey has embraced this “whole-body” approach where a clinician is equipped with a broad medical knowledge base allowing them to address a variety of needs of patients and study participants. In addition, she notes that she has found great value in considering all factors that contribute to successfully managing HIV and preventing known risk factors in the development of both mental and physical disease processes.

    “Our study participants, like all people, are complex psychological and biological beings and they come to us with a wide variety of needs, beyond just HIV care,” said Dr. McComsey. “For example, nutrition and exercise can have a big impact on someone’s physical and mental health. In order for a person living with HIV to be successful in managing their health, he or she must receive guidance on more than just treating HIV.”

    Dr. McComsey is also passionate about the research she conducts surrounding stigmatizing fat changes that not only affects quality of life but also increases risk of cardiovascular disease (CVD), diabetes, and other chronic conditions seen in patients living with HIV. Although research has come a long way in understanding the connection between alterations in fat tissue and HIV itself, as well as the drugs used to treat HIV, there is still much to learn about how to prevent these co-morbidities. Additionally, Dr. McComsey believes that the future of clinical trial research in managing HIV and metabolic complications should focus on more than just developing new antiretroviral medications and finding a cure for HIV. She believes it is increasingly important to develop, test, and implement strategies and interventions that will help people with HIV live the healthiest and fullest life possible.

    “We know that people living with HIV who take antiretroviral medications have increases in visceral fat and in CVD, which is one of the top causes of death in people taking HIV medications with good adherence,” said Dr. McComsey. “We are closer than ever to a fully equal life expectancy between people living with HIV compared to those without HIV and taking control of fat and heart issues will likely further close this gap in life expectancy.”

    HIV and the inflammation that comes with the virus can have devastating effects on the heart, the gut, the nervous system, muscles, fat, and other parts of the body. Dr. McComsey suggests that caring for a patient living with HIV requires a holistic “whole-body” approach to healthcare. This involves considerations including lifestyle choices, cardiovascular health, gastrointestinal health and psychiatric health. In addition, she notes that having undetectable viral load and high CD4 should be the minimum, not the only goal of successful HIV treatment.

    One mentor that has shaped Dr. McComsey’s view on the importance of clinical research is Michael Lederman, MD, Professor of Medicine at Case Western Reserve University School of Medicine and University Hospitals of Cleveland. She learned from Dr. Lederman early in her career that if you want to be successful in research, you have to “eat, drink and dream research.” When she was younger, she was skeptical about his advice, but the current (older and wiser) version of her is convinced Dr. Lederman was absolutely correct.  It is clear that the two share a mutual respect of one another. 

    “Grace is one of the most efficient, effective and productive researchers I have ever known. Not only is she is passionate about her work, she is also dedicated to her patients and a dynamic role model and mentor for young researchers,” said Dr. Lederman. “Grace has made many early and sustained landmark contributions to our understanding of the metabolic and inflammatory consequences of HIV infection and their role in the morbidities of HIV infection.  She’s a star!”

    Regardless of the specific research project, Dr. McComsey’s body of work continues to characterize the role of inflammatory markers on heart disease in chronic diseases such as HIV. She encourages all ACTG Network researchers to take the time to understand the role of inflammatory processes in order to understand the intersection of multiple diseases. She also wishes to remind her fellow researchers that fat may be playing a major role in the heightened systemic inflammation in patients and study participants and that means everyone should care about fat, not just those working in this specific area.

    In closing, Dr. McComsey also has an important message to patients and study participants living with HIV:

    “Take great care of yourself, eat healthier and exercise as you are at an increased risk for diabetes and heart disease. We can beat HIV itself but we need you to be extra diligent in living a healthy life. We know that adequate exercise, a balanced diet, and a positive mental attitude are essential to preventing some of the long-term damage caused by HIV, but we still have a lot to learn and we need your help. Your experience and participation is invaluable to the clinical trial research conducted across the ACTG Network!”

  • Wits HIV Research Group ACTG Site

    January 1, 1970 pendari Sites

    [Spotlight originally posted January, 2011]

    “Research must include investigation into opportunist infections such as TB, as HIV cannot be looked at in isolation.”  –Dr. Prudence Ive, Wits HIV Research Group ACTG Clinical Research Site Principal Investigator, and CMC member of the ACTG A5221, Johannesburg, South Africa.

    Tuberculosis (TB) and the emerging multi-drug resistant (MDR) TB epidemic represent a major challenge to human immunodeficiency virus (HIV) care and treatment programmes, particularly in resource-limited environments. TB in South Africa has always been a problem historically and there is an exponential rise in TB due to HIV.

    TB is a major cause of mortality among patients with HIV and represents risk throughout the course of HIV disease, even after successful initiation of antiretroviral treatment (ART). Progress in the implementation of activities directed at reducing TB burden in the HIV population still lags behind global targets.

    HIV programmes designed for long-term care are ideally suited to implement TB control measures and must address TB rigorously to save patient lives and safeguard investment in HIV the treatment programme.

    Dr. Ive is the site-PI and member of the clinical management committee of the recently completed A5221 study. She explains that trials have had to branch out into opportunist infections like TB, malaria and cervical carcinoma and HIV cannot be looked at in isolation. The study, which began in 2007 and was completed in August 2010, specifically evaluates whether following the starting of TB treatment, ART should also be started immediately (within two weeks) or deferred by 8-12 weeks. Study participants must have CD4 counts of less than 200 cells per mm3.  The study has been evaluated and results will be presented at the upcoming Conference for Retroviruses and Opportunistic Infections in Boston (CROI Feb 2011).

    “Our observational studies from the Themba Lethu Clinic at Helen Joseph Hospital, have found that once patients are on ARTs, the instances of TB go down dramatically,” comments Dr. Ive. “Patients stable on ARTs are less likely to contract TB however we are still finding it difficult to treat patients that have contracted MDR TB, many of whom appear to come from the same source in KwaZulu Natal.”

    About the Wits HIV Research Group ACTG Site

    The Wits HIV Research Group ACTG site, based at the Helen Josef Hospital in Johannesburg, South Africa, is one of multiple sites worldwide conducting the ACTG international studies. The site has been active in the ACTG since 2002, under the Clinical Trials Unit (PI – Ian Sanne). Dr. Prudence Ive was appointed as CRS Principal Investigator in December 2008 and the site has continued with its record of success under her leadership. The Helen Joseph Hospital is a secondary level hospital, and part of the academic circuit of the Faculty of Health Sciences, University of the Witwatersrand. The research site is integrated with the HIV treatment centre, and TB focal-point, with over 27,000 HIV patients on care, treatment and support, the site is ideally suited to enrol patients in the current and future agenda of the ACTG network. 

    The ACTG site in Johannesburg, South Africa, is one of the leading international sites in the network, participating in a number of the network studies (5073, 5164, 5175, 5207, 5208, 5221, 5255, 5253 and the related sub-studies).

    Key to the success of the research unit has been the exemplary follow-up of patients, with less than 1% of research participants being LTFU. “On the other hand, a particular positive is our very strong and efficient infrastructure that enables us to monitor adherence to programmes and offer counseling as and when required. Adherence to treatment regimens definitely makes a difference to patients,” she emphasises.

    Dr. Prudence Ive
    MBBCH, FCP(SA), DTM&H, Dip. HIV Man (SA)

    Specialist physician, Dr. Prudence Ive has been a clinical investigator on the NIH-sponsored ACTG trials in the CIPRA-SA programme and ACTG network as site Principal Investigator at the Wits HIV Research Group (WHRG) based at the Helen Josef hospital in Johannesburg.

    Dr. Ive completed both her undergraduate and post-graduate training at the University of the Witwatersrand, Johannesburg, South Africa. She obtained her diploma (cum laude) in tropical medicine and hygiene in 1997 and her HIV management diploma in 2004.

    Dr. Ive was the medical director of the Themba Lethu HIV clinic from 1996 until 2005 during which time thousands of patients were initiated on antiretroviral therapy and a strong relationship was forged between the clinic and the WHRG. She joined the WHRG in 2000 but has maintained a consultancy relationship with the Themba Lethu clinic.

    Currently the WHRG’s deputy director, Dr. Ive has been principal investigator on many HIV clinical trials, some of which were new drug development trials sponsored by the pharmaceutical industry. Dr. Ive was an investigator on the CIPRA 1 grant funded by the NIH and was part of the team that developed and successfully executed the protocol.

    Dr. Ive continues to lecture and examine GEMP 4 medical students, mentors post-graduate researchers in the Health Economics and Epidemiology Research Office, and provides clinical teaching at post-graduate level in the Faculty of Health Sciences, University of the Witwatersrand.

    (pictured above: Dr. Prudence Ive, Wits HIV Research Group ACTG Clinical Research Site Principal Investigator)

  • Lilongwe, Malawi

    January 1, 1970 pendari Sites

    [Spotlight originally posted September, 2010]

    It all has not been an easy road for the ACTG clinical research site team at the University of North Carolina (UNC) Project in Lilongwe, Malawi, but our team is one of the proudest to have been involved in this network’s studies. The UNC Project is located on the Kamuzu Central Hospital premises. The project undertakes studies for various NIH Division of AIDS networks, including the ACTG, HPTN, IMPAACT, MTN, and the Center for HIV-AIDS Vaccine Immunology, PATH Malaria Vaccine Initiative, and International Partnership for Microbicides. The CRS was started in 2006 with the ACTG study A5175 and its associated studies; the A5185, A5190, and A5199. Thereafter, the team has also participated in other ACTG studies including A5208, A5221, and A5230. Notably, our site was the highest accruing site for both A5221 and A5230.

    Currently, we are actively following patients on A5230 and are anxiously awaiting the opening of 5253, 5271, and 5264, for which we are awaiting site activation or are under review with the ethics committee. In the coming year, we hope to participate in A5274 (our own site PI, Dr. Mina Hosseinipour is the co-chair of the protocol), A5263, A5273, and A5288. The site’s choice of protocols closely mirrors the greatest research needs of Malawi.

    Each of the members of the study team has their own experiences of working in the ACTG studies. According to Dalitso Mzinganjira, the primary research nurse for the A5230, what he has liked most about this study is that the retention rate has always been 100%. This male nurse was the only one conducting the study, and he just recruited the last client in July 2010. “Among some of the challenges that this study encountered was lack of viral test kits at some moments in the study when I had to wait for at least two weeks,” for supply of kits he said.

    Another research nurse, Esnart Mtika, who was responsible for A5175, was very positive about her experiences when she says she was happy to see some clients who joined the study while having a very low CD4 count regaining healthy bodies over the course of the study. “Of course we also had the challenge of poor adherence by some clients to the study drugs. This adversely affected their health, which was also not good for the study outcome,” she says. Mtika’s views on poor adherence are also shared by another nurse, Charity Potani, who has been conducting A5208. “When clients didn’t adhere to the study drugs, we had to use more energy to bring them back into the right track. We had to involve a lot of counseling.”

    However, Regina Mwausegha, a nurse who has been conducting the A5221 study, likes the fact that her site was the first one to complete enrollment among the other sites. She is optimistic about getting actively involved in the upcoming A5271 and A5264 studies for this site. “This (A5221) study has been a success, for in the study we have received clients from the Kamuzu Central Hospital who came in very poor health but picked up very well when they were in the study,” she says. For Mwausegha, one of the challenges that quickly comes to mind is that there were so many people to screen, making enrollment a slow process. She also says others were not willing to have their blood samples taken for lab tests since the volume of blood seemed high.

    The Lilongwe ACTG team is also proud to have worked with other departments that have contributed to the smooth running of the studies. These are: the community department which has been instrumental in the tracing of study clients, the pharmacy which dispensed prescribed drugs, the laboratory which carried out the tests, and even the drivers, among others.

  • Step Inside the ACTG's Only Site in Thailand

    January 1, 1970 pendari Sites

    The Chiang Mai University Adult Clinical Trials Group Clinical Research Site (CMU ACTG CRS) was first established as an AIDS Clnical Trials Group international clinical trial unit (ICTU) in February 2004. The Chiang Mai ICTU is the first and only clinical research site in Thailand affiliated with the ACTG Network and is the first ACTG ICTU to enroll patients in Asia. The site is one of the first sites, with Malawi, to enroll patients to the worldwide multi-site A5175 (PEARLS) trial (June 16, 2005).

    The CMU ACTG CRS is located in the same campus as the CMU Faculty of Medicine, which is an 1,800-bed tertiary-care hospital serving all of northern Thailand. The CMU infectious disease clinic at the CMU Faculty of Medicine Hospital currently has a cohort of more than 1,300 HIV-infected adults being treated with several antiretroviral (ARV) regimens, most commonly the Non-Nucleoside Reverse Transcriptase Inhibitors- or NNRTI-based regimen. The clinic recruits participants from the provincial and community hospitals around the Chiang Mai area. These recruitment sites provide access to a large pool of both anti-retroviral naïve and NNRTI-experienced potential participants who are infected with the HIV-1 CRF01 A/E clade. In addition, the clinic has the opportunity to recruit participants from the ethnic minority population along the borders of Thailand with Myanmar and Laos as well as to expand the site to cover populations in Southeast Asian countries around northern Thailand, i.e., Myanmar, Laos, and Vietnam. All the site staff is trained in Good Clinical Practice (GCP) and Human Subjects Protection. Laboratory personnel are certified in Good Laboratory Practice (GLP).

    “It’s great working at Research Institute for Health Sciences,” says Daralak Tavornprasit, the Clinical Research Site Coordinator. “We have a great team, work in a great environment and aim to conduct great research.”

     The CMU ACTG CRS is under the administration of the Chiang Mai University HIV/AIDS Clinical Trials Unit (CMU HIV/AIDS CTU) led by Thira Sirisanthana, MD. This CTU currently has three Clinical Research Sites (CRS). The first site is the CMU AIDS Clinical Trials Group Clinical Research Site (CMU ACTG CRS), headed by Khuanchai Supparatpinyo, MD, focusing on research priorities in optimization of clinical management in the adult HIV-infected population.

    The second site is the Pediatrics-Obstetrics Clinical Research Site (CMU PED-OB CRS), headed by Virat Sirisanthana, MD, focusing on research priorities in mother-to-child transmission of HIV, as well as optimization of clinical management in children, adolescents and pregnant women.

    And finally, the Chiang Mai University AIDS Prevention and Microbicide Clinical Research Site (CMU AIDS Prevention CRS), that is headed by Suwat Chariyalertsak, MD, under the Southern Asia HIV/AIDS Clinical Trials Unit, Johns Hopkins University (JHU) Bloomberg School of Public Health. To maintain cost efficiency, all the sites share the CTU resources by using the same core competency teams, i.e., administration, financial management, pharmacy, clinical laboratory, specimen processing, regulatory compliance, staff training, quality management, data management and community advisory boards. The CTU investigators have expertise in pharmacokinetics trials, HIV epidemiology and behavioral interventions, HIV vaccines, HIV prevention and HIV treatment trials. Several members of the ACTG, PED-OB and HPTN CRSs participate in the network’s protocol teams and scientific committees.


    January 1, 1970 pendari Sites

    The Asociación Civil Impacta Salud y Educación (IMPACTA) has been dedicated to basic science, epidemiological, clinical, and operational research in Peru since year 2000. The IMPACTA Peru Clinical Trials Unit has two clinical research sites (CRS) participating in ACTG studies and serving separate areas of Lima, a city with more than 8 million people. CRS 11301 is located in the district of Barranco (Southern Lima) and CRS 11302 located in the district of San Miguel (Northwestern Lima). Contributions of these sites to ACTG studies include A5175, A5199, A5217, A5221, A5227, A5234, A5250, A5253, A5255, A5259, A5271, and PROMISE. Studies about to open include A5273, A5274, A5279, A5282, and A5288. Several members of our team participate in ACTG protocol teams and ACTG scientific committees. Impacta has also contributed to the research agenda of other NIH networks such as HVTN, HPTN, and INSIGHT, and is preparing to begin MTN studies.

    Impacta is the pioneer in HIV prevention research in South America aimed at high-risk populations, such as men who have sex with men. Under the Comprehensive International Program for Research on AIDS (CIPRA) we conducted the first third-generation sentinel surveillance program for the Andean region. The knowledge gained is now used as a reference for developing public health strategies in the country and the region.

    Effective networking has been the cornerstone for the success of IMPACTA. Strategic alliances and technical cooperation with national or international governmental, academic, and scientific institutions has been consolidated. Both sites 11301 and 11302 are sites providing care under the Peruvian Ministry of Health National Antiretroviral Therapy Program.

    Such multiple and diverse activities are coordinated by resource units such as the laboratory unit, the biostatistics, informatics and data management services (BIDS) unit, the community education and involvement unit, and the clinical research unit. An independent Ethics Committee provides oversight of all our activities to maximize human subject protection.

    The Community Education resource unit provides successful recruitment of study participants. It is supported by the PLUS Network comprising more than 12 hospitals and 21 health care centers that are actively involved in referring potential participants. A Community Advisory Board, compose by 12 members, is a successful communication channel between researchers and the community-at-large, providing input from different target communities recruited in our studies. Finally, development of educational materials and educational and outreach activities are directed to the community.

    Our staff is proud of our accomplishments with the ACTG, and we are grateful for the technical and scientific mentoring we continue to receive from the network. Our personnel are now highly qualified in all areas of research. The knowledge being generated is already impacting practice in our country. We look forward to continuing and expanding the contributions of our team to the scientific agenda of the network.

  • Fiocruz

    January 1, 1970 pendari Sites

    It has been a major accomplishment for our Clinical Trials Unit (CTU) at Instituto de Pesquisa Clinica Evandro Chagas (IPEC) – FIOCRUZ – to become affiliated with the AIDS Clinical Trials Group (ACTG). We joined the network in 2002, when the first international ACTG study – A5175 – started to be developed. Along these years, we have been successful in building a well-trained and dedicated multidisciplinary team that is able to meet the high-performance standards required by ACTG. Besides the highly experienced study coordinators, clinicians, pharmacists, nurses, and laboratory technologists and community educators, our CTU receives the support of a community advisory board that represents our diverse community.

    Our CTU is based at IPEC, a 90 year old institution fully dedicated to clinical research in infectious diseases. IPEC is one of the 17 research institutes that integrate the Oswaldo Cruz Foundation (FIOCRUZ). FIOCRUZ is a public health institution for research and development in biomedical sciences. It is part of the Brazilian Ministry of Health, being the largest public health institution in Latin America.
    The IPEC site is one of the leading international sites in the ACTG network. Since we joined the network, we have participated in several studies, having started with A5175 and its associated studies the A5185, A5190, and A5199. Thereafter, the team has also participated in other ACTG studies including A5221, 5227, A5240, A5234, A5243, A5253, 5255, and A5259. Notably, our site was one of the highest accruing sites for A5275, A5227, and A5240. In the coming year, we hope to participate in A5271, A5274, A5263, A5264, A5273, A5288 (our own site PI, Dr. Beatriz Grinsztejn is the co-chair of the protocol), A5295, and A5298.
    The site’s choice of protocols closely mirrors the greatest research needs of Brazil, and we prioritize antiretroviral therapy strategy studies, tuberculosis, and HPV studies.
    Tuberculosis still stands as a disconcerting serious public health problem, as this disease is still far from being controlled. Brazil ranks 16 out of the 22 countries that present 80% of the world’s TB cases. Among the AIDS cases reported to the Ministry of Health, tuberculosis represents the most important AIDS-associated disease and the main cause of death among AIDS patients. A strong and longstanding collaboration exists between IPEC/FIOCRUZ and several TB Control Programs in Rio de Janeiro State. Our site is a referral center for HIV/TB adult coinfected patients in Rio de Janeiro State. Therefore, studies related to TB diagnostics, prevention, and treatment are among those with the highest priority.
    At IPEC we have available inpatient and outpatient facilities, a day hospital, a well-established diagnostic center, a data management unit, a dedicated clinical trials pharmacy, a specimen processing laboratory, and a biological specimen repository. This high-level research infrastructure contributes to a high recruitment and a very low rate of lost to follow up of study patients. We are truly proud to be part of the network.